Senior Biostatistician X3 Job at CSL Plasma, King of Prussia, PA

bTNxVDRpSmFML1hCZjhvNno1VmFCNFJtM2c9PQ==
  • CSL Plasma
  • King of Prussia, PA

Job Description

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Senior Biostatistician? The job is in our King of Prussia, PA, Waltham MA and Zurich Switzerland Office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats.

The Senior Biostatistician provides and may lead statistical components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables.

Responsibilities:

1. Input to statistical strategy and ensure appropriate statistical methodologies applied to study
design and data analysis for clinical trials and regulatory submissions.
2 Provide statistical support in data collection, data analysis, reporting, and submission
preparation.
3 Be accountable for timely completion and quality of the statistical analysis plan.
4 Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)
5 Be responsible for interpreting analysis results and ensuring reporting accuracy.
6 Manage outsourcing operations or work with internal statistical programmers within the
responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct
reviews of deliverables to ensure quality.
7 Be accountable for the TFL/CDISC package for study report and regulatory submission.
8 Support improvement initiatives and related standards for infrastructure / process / scientific
consulting

Qualifications:

PhD or MS in Biostatistics, Statistics or related field
Experience PhD or MS with1-2 years of experience in drug
development
Competencies -Advanced knowledge and training in applications of statistical methodologies in the context of clinical development

#LI-HYBRID

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit .

Job Tags

Full time, Work at office, Worldwide, 3 days per week,

Similar Jobs

California Retina Consultants

Ophthalmic Scribe (Retina & Uveitis) Job at California Retina Consultants

 ...Ophthalmic Scribe (Retina & Uveitis) Job Summary This position provides specialized...  ..., referral, and treatment workflows for medical retina and uveitis patients....  ...Spanish (Required). Education and Experience: High school diploma or equivalent... 

BITZER US

TIG Welder Job at BITZER US

 ...Summary (Position Description): Skilled Welder for fabrication ValueAdd ACP units at our facilities, while meeting all the ASME code...  ...cranes are a plus. Requirements: TIG Welding experience MIG Welding experience Pulse Arc Welder experience Work Environment... 

Ferrero

Category Space Planning Analyst Job at Ferrero

About the Role: With new innovations and exciting expansions plans in place, there has never been a better time to join the Ferrero Group and be extraordinary with us! As the Category Capability Analyst, CCC & Spreads, you will play a key role in driving the growth...

Stansell Construction

Construction Project Manager - Quick Service Restaurant Job at Stansell Construction

Stansell is seeking a talented Project Manager in the Michigan region to join our team! POSITION IS REMOTE. CANDIDATE MUST RESIDE IN MICHIGAN AND BE ABLE TO TRAVEL TO JOBSITES REGULARLY AND OUR OFFICES FOR OCCASIONAL TEAM EVENTS. Stansell is a rapidly growing...

The Trustees of Reservations

Horticulture Intern Job at The Trustees of Reservations

 ...Housing Provided WhatYoullDo: Your Impact: This is a one-of-a-kind opportunity for a person with a passion for horticulture, plants, and historic landscapes. Join our expert team inmaintainingNaumkeag, one of the premier public gardens in Massachusetts...